BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRAGG-MCNAMARA VALVED INFUSION CATHETER

    MDR report key: 311696 · Received January 11, 2001

    Report

    Report Number
    311696
    Event Type
    Other
    Date Received
    January 11, 2001
    Date of Event
    December 12, 2000
    Report Date
    December 26, 2000
    Manufacturer
    MICRO THERAPEUTICS, INC
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PHARMACOMECHANICAL THROMBOLYSIS OF LEFT FOREARM AV SHUNT GRAFT WITH PTA ARTERIAL ANASTOMOSIS AND VENOUS OUTFLOW, WITH CENTRAL VENOGRAPHY ON 12/12/2000 IN THE RADIOLOGY DEPT. DURING THE PROCEDURE A SMALL METALLIC BAND BEING APPROX 1 MM IN DIAMETER BY 1 MM IN SIZE, WHICH APPARENTLY LOOSENED FROM ONE OF THE MTI CATHETERS AND APPEARS TO BE IN AN INTEROSSEOUS ARTERIAL BRANCH. AT THE TIME OF THE PROCEDURE, IT WAS NOT OCCLUSIVE AND FLOW WAS SEEN THROUGH THIS RING-LIKE STRUCTURE INTO THIS PORTION OF THE BRANCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216 CRAGG-MCNAMARA VALVED INFUSION CATHETER VALVED INFUSION CATHETER DQO MICRO THERAPEUTICS, INC UNK 650474J

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other